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`PGR2015-00011, Paper No. 47
`August 10, 2016
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`ALTAIRE PHARMACEUTICALS, INC.,
`Petitioner,
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`v.
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`PARAGON BIOTECK, INC.,
`Patent Owner.
`____________
`
`Case PGR2015-00011
`Patent 8,859,623 B1
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`Held: July 12, 2016
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`BEFORE: ZHENYU YANG, CHRISTOPHER G. PAULRAJ,
`and SHERIDAN K. SNEDDEN, Administrative Patent Judges.
`
`
`The above-entitled matter came on for hearing on Tuesday, July
`12, 2016, commencing at 2:00 p.m., at the U.S. Patent and
`Trademark Office, 600 Dulany Street, Alexandria, Virginia.
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`571-272-7822
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`PGR2015-00011, Paper No. 47
`August 10, 2016
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`ALTAIRE PHARMACEUTICALS, INC.,
`Petitioner,
`
`v.
`
`PARAGON BIOTECK, INC.,
`Patent Owner.
`____________
`
`Case PGR2015-00011
`Patent 8,859,623 B1
`____________
`
`Held: July 12, 2016
`____________
`
`
`
`
`BEFORE: ZHENYU YANG, CHRISTOPHER G. PAULRAJ,
`and SHERIDAN K. SNEDDEN, Administrative Patent Judges.
`
`
`The above-entitled matter came on for hearing on Tuesday, July
`12, 2016, commencing at 2:00 p.m., at the U.S. Patent and
`Trademark Office, 600 Dulany Street, Alexandria, Virginia.
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`DIPU A. DOSHI, ESQUIRE
`JONATHAN W.S. ENGLAND, ESQUIRE
`Blank Rome, LLP
`1825 Eye Street, N.W.
`Washington, D.C. 20006
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`MICHAEL ROSATO, ESQUIRE
`SONJA GERRARD, ESQUIRE
`Wilson, Sonsini, Goodrich & Rosati
`701 Fifth Avenue
`Suite 5100
`Seattle, Washington 98104-7036
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`Case PGR2015-00011
`Patent 8,859,623 B1
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`APPEARANCES:
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`ON BEHALF OF THE PETITIONER:
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`ON BEHALF OF PATENT OWNER:
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`Case PGR2015-00011
`Patent 8,859,623 B1
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`P R O C E E D I N G S
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`JUDGE YANG: Good afternoon, everyone. This is the
`hearing for PGR2015-00011. The patent in suit is U.S. patent
`number 8,859,623. Now, counsel, would you please introduce
`yourselves, please, starting from the petitioner.
`MR. DOSHI: Good afternoon, Your Honor. Dipu
`Doshi on behalf of petitioner, Altaire Pharmaceuticals, Inc. With
`me are Mark Bronson and Jonathan England.
`JUDGE YANG: Thank you. Welcome. Patent owner?
`MR. ROSATO: Good afternoon. Mike Rosato
`representing patent owner, Paragon BioTeck. And with me at
`counsel table is Sonja Gerrard.
`JUDGE YANG: Thank you and welcome. We have
`just a couple of housekeeping matters before we begin. As set
`forth in the trial order, each party has 45 minutes to present your
`argument. Petitioner will proceed first and patent owner to
`follow. Petitioner, you can reserve time for rebuttal, but during
`your rebuttal time, you can only respond to the argument that
`patent owner raised during their response time.
`We set 45 minutes. That's the maximum. You really
`don't have to fill every second. Second is the demonstratives.
`Both parties e-mailed us the demonstratives. Thank you. When
`you discuss the demonstratives, please be specific. Please
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`identify the slide number so when we read the transcript, we
`know what we are talking about. And this goes with all the other
`papers and exhibits, if you pull up a paper, tell us what the paper
`number is, the Exhibit Number, the page number, line number,
`whatever is necessary.
`One last but very important issue, that is please don't
`interrupt each other when the other party is presenting. If you,
`for whatever reason, have an objection, you can raise it during
`your own time. So patent owner, if you have any objection
`during petitioner's opening, do it during your response time. But
`if you have any objection during the reply time, you can just
`bring it up before we adjourn. And petitioner, you can raise your
`objection during your reply time.
`So if there is no questions, petitioner, would you like to
`reserve any time for rebuttal?
`MR. DOSHI: Yes, Your Honor. I would like to reserve
`15 minutes for rebuttal.
`JUDGE YANG: So you may begin whenever you are
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`ready.
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`MR. DOSHI: Thank you, Your Honor. I have hard
`copies of the demonstratives. Do you need those?
`JUDGE YANG: Yes, that would be good.
`MR. DOSHI: May it please the Board, good afternoon.
`My name is Dipu Doshi for petitioner, Altaire Pharmaceuticals,
`Inc. Along with me, as I said previously, Mark Bronson and John
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`England. I'll take you to slide 2 here. We are here to determine
`whether claims 1 through 13 of the '623 patent are unpatentable
`as obvious over Altaire's product. The petitioner submits that it
`has met its burden, it's met its burden by a preponderance of the
`evidence. The evidence is clear, it's well documented, it's
`compelling and in many instances it's uncontroverted.
`The parties are no strangers. I have turned to slide 3.
`This is an agreement or excerpts of an agreement between
`Altaire, the petitioner, and Paragon, the patent owner. As you can
`see, the agreement was executed in 2011. The parties are still --
`are in a District Court dispute regarding the contract, but there is
`no pending patent infringement suit or declaratory judgment in
`the District Court proceedings. But the main point here is to
`understand that the parties are no strangers to one another. They
`have been working together and they continue to work together
`under this agreement. And as part of the agreement, petitioner
`would become the exclusive manufacturer and supplier of certain
`products that were covered by an NDA that were filed by -- the
`NDA was filed by patent owner, and the patent owner would
`become the exclusive marketing arm and distributor of those
`products. Down at the bottom of slide 3, you can see that the
`term is ten years from the date of the execution, which would put
`it at 2021.
`So the Board may be asking why are we here if the
`parties are working together. Well, there's a District Court
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`Patent 8,859,623 B1
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`dispute, as the Board may know, and in that Paragon, the patent
`owner, has requested termination of the contract. And as a result,
`petitioner may be at risk of a patent infringement action by patent
`owner should the court grant such relief. And then it may be at
`risk of the patent infringement suit for products that it has been
`selling prior to the effective filing date of the '623 patent.
`I'm going to skip to slide 5. As shown on slide 5, which
`takes a little bit of time, there it is, lots 11578 and 11581 are
`examples of the products that were sold prior to the effective
`filing date, sold and distributed. And they meet each and every
`limitation of the challenged claims, claims 1 through 13, and at
`the very least render the claims obvious.
`Slide 6 shows claim 1 of the '623 patent. Rather than
`address the limitations, each and every limitation, I'll address
`those that are materially in dispute here between the parties,
`which is the chiral purity and the cold storage limitations.
`JUDGE YANG: Counsel, let me just stop you there.
`Do you agree that the USP standard HPLC method cannot
`separate the S form and the R form?
`MR. DOSHI: We do not concede that, but the USP
`HPLC method is not what Altaire or petitioner has used to show
`that the products were chirally pure.
`JUDGE YANG: I understand that part. I am more
`curious about your position on the USP standard method. Does it
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`do the job or does it not? As you know, patent owner asserts that
`the standard HPLC cannot separate the S and the R form, right?
`MR. DOSHI: That's correct, but that is not the method
`that we used. We used the HPLC method that is detailed by
`Mr. Sawaya in his declaration which does distinguish between the
`R and S enantiomers and isomers and can detect -- I'm sorry.
`JUDGE YANG: I understand that's your assertion.
`What I was a little troubled with is when I first looked at the
`petition, I noticed you mentioned that -- this is on page 20 of the
`petition where you mention the Altaire proprietary HP -- and
`validated HPLC procedure. The code is TMQC-247. That's the
`one you are talking about, correct?
`MR. DOSHI: That's correct.
`JUDGE YANG: Right. Later in the petition, this is on
`page 49, the last sentence, it does talk about using that method,
`and again on page 61 you talked about the TMQC-247. Those
`are the three places you mentioned this testing method, but none
`of them actually was mentioned during the discussion of the two
`products you were -- we finally instituted on, the two you just
`showed. The three places you specifically mentioned that you
`use this testing method, you did that -- the well, it appears that
`those three places had nothing to do with the two products you
`were just discussing. So that's the reason. Can you point to me
`somewhere in the petition that would lend some support to show
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`that the two HPLC data you obtained for the two products we
`instituted on were performed using this specific method?
`MR. DOSHI: Sure, Your Honor. What I put up on the
`slides here is slide 17, which is Exhibit 1020 accompanying the
`petition. And here we have the TMQC-247 in the note
`highlighted at the bottom of the slide there --
`JUDGE YANG: Which product are we talking about?
`MR. DOSHI: We are talking about the drug substances
`used in the manufacture of phenylephrine.
`JUDGE YANG: But it is not the specific product,
`right? It's the underlying product, the so-called active ingredient
`that went into the product; is that correct?
`MR. DOSHI: That is correct, Your Honor. It was used
`to manufacture lot numbers 11578 and 11581. Mr. Sawaya's
`testimony also confirms that throughout his declaration he was
`referring to TMQC-247 test methodology, the proprietary
`petitioner HPLC methodology, not the USP HPLC methodology.
`And he reiterates in several places that the HPLC method that is
`being used can detect up to as little as .1 percent S isomer. And
`therefore, it shows that the HPLC methodology that was being
`employed by petitioner was one that could distinguish between
`the two isomers, not something that you would -- not the USP
`HPLC methodology which patent owner at least says it is not --
`cannot distinguish between the R and S isomers.
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`JUDGE PAULRAJ: So I'm going to refer you to your
`petition again, page 36, footnote 10. And this, I believe, is the
`section referring to specific products upon which we instituted
`on. And here footnote 10 refers to USP guidelines. So can you
`explain your position with respect to your reliance on the USP
`guidelines here for showing chiral purity here?
`MR. DOSHI: Well, the way we tried to put it was that
`it was validated. The HPLC methodology that was used to
`determine -- that can distinguish between the R and S isomers
`was validated pursuant to the USP pharmacopeia guidelines.
`That's what we were referring to is that it followed the guidelines
`of validation, part of the validation protocol that's given by the
`USP or established by the USP.
`JUDGE PAULRAJ: So you don't actually refer to the
`proprietary test method in this section. I think that was also
`Judge Yang's concern here; is that right? Let me stop right there.
`Do you refer to that proprietary test method in the discussion with
`respect to footnote 10 and accompanying discussion and text?
`MR. DOSHI: In footnote 10 specifically, I would have
`to -- not in footnote 10, obviously, just reading it here. But I'll
`continue looking to see if there's something that I can --
`JUDGE PAULRAJ: Is there something I'm missing
`here? Obviously I read this section as well and didn't see
`anything specific with respect to that proprietary method or basic
`code name for that method. My question is, is there anything that
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`we should read in this discussion that would suggest referring to
`the proprietary method?
`MR. DOSHI: I would -- not in footnote 10. And I
`will -- I can search, but I think my time would be better spent --
`JUDGE YANG: If you find something, you can just
`give it to us later.
`MR. DOSHI: Thank you very much, Your Honor. I
`will note, though, that the chromatograms for 11581 and 11578
`were compared against chromatograms that were run for another
`sample, and that was Exhibit 1015. And Exhibit 1015 certainly
`shows that there are two peaks, one that's labeled R isomer and
`one that's labeled S isomer. And one elutes out at 7.6 minutes
`and one elutes out at 9.2 minutes, I believe. And that will
`corroborates Mr. Sawaya's testimony on paragraphs 22 and 23 of
`his declaration suggesting that -- not suggesting, but affirming
`that the HPLC methodology that was being used could
`distinguish between the R --
`JUDGE YANG: We understand that part. The
`proprietary method does distinguish the two peaks, yes. We were
`just curious where in the petition can we find information to
`affirmatively find that this method was used for the two products
`we instituted on.
`MR. DOSHI: Your Honor, the only HPLC
`methodology that was referred to by the petitioner was the
`TMQC-247. So that certainly is evidence of testing of the 11578
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`and 11581 lots using the HPLC methodology that can distinguish
`between the two isomers. There's no USP HPLC method or
`chromatograms or testing that's discussed other than the HPLC
`testing of the proprietary, if you will, methodology.
`JUDGE PAULRAJ: Notwithstanding what's stated in
`footnote 10?
`MR. DOSHI: Again, we understood this to validate
`pursuant to an established USP guideline. So these were the
`guidelines that were set up to validate an HPLC methodology that
`can distinguish between the R and S, to test its robustness, its
`reliability and reproducibility. That's what footnote 10 was meant
`to be. And that's, I believe, corroborated by Mr. Sawaya in
`Exhibit 1003.
`JUDGE PAULRAJ: And to confirm, you actually --
`with the petition, you didn't include the proprietary method, right?
`That wasn't included as an exhibit until the reply?
`MR. DOSHI: The actual proprietary protocol?
`JUDGE PAULRAJ: Yes.
`MR. DOSHI: The full validation was not put in until
`the reply brief, but there is ample evidence in the petition and
`Mr. Sawaya's declaration and the accompanying documents that
`show that it was a high-performance liquid chromatography test
`that the -- I'm sorry, that it was the TMQC-247 test. He testified
`as to preparation of the samples, the elution rates for both the R
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`and S isomers and the total area of the peaks as well that he was
`referring to.
`I'll take you back to slide 17 here in Exhibit 1020. This
`accompanied the petition and was testified to -- or Mr. Sawaya
`testified to this exhibit as well. And the note down at the bottom
`states that it's TMQC-247. It provides the column, diameter, the
`column type, the wavelength at which the samples were
`measured. So all of the information that was necessary for the
`HPLC methodology to be run or to be tested against was provided
`within the petition.
`JUDGE PAULRAJ: So your opinion is that everything
`that's stated here would be, that's all that's needed to be able to
`run this method?
`MR. DOSHI: That's correct, Your Honor.
`JUDGE PAULRAJ: You don't need to know the actual
`methodology that's provided in the later exhibits, 1027 --
`MR. DOSHI: Well, I think the methodology was
`provided by Mr. Sawaya in his testimony in the declaration where
`he states that it was an HPLC method, that it was the preparation
`of the samples, et cetera. Those were the things that are needed.
`The validation report basically corroborates his testimony that the
`HPLC methodology can distinguish between the R and S isomers.
`That's really what it comes down to is STU0346 which is -- that
`that was put in the reply brief, that was a validation report that
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`shows the reproducibility and robustness of the HPLC method
`that was used.
`JUDGE YANG: Is Mr. Sawaya qualified to testify on
`the methodology?
`MR. DOSHI: Yes, Your Honor, he is. He is not only
`president of Altaire and not only has firsthand knowledge and
`observation of the facts that were presented in the petition, but he
`has 40 years of experience in the --
`JUDGE YANG: Yes, I understand that. We saw his
`CV and it was very impressive. But the issue is in the declaration
`accompanying the petition, all we had was the first sentence that
`he is the president and he made the declaration based on his
`personal knowledge. So based on that, can you explain how and
`why we should treat him as an expert?
`MR. DOSHI: Yes, Your Honor. I think just if you look
`at the declaration, throughout his declaration, he attests to the fact
`that these tests can distinguish between the R and S isomers. He's
`been president of Altaire that has been selling these products for
`over a decade now, since 2004 and 2005. We have labels to show
`it in our petition. And you can see from his declaration that he
`has firsthand knowledge of all of these testing, that he
`understands the current laboratory practices, it is necessary that
`these HPLC methods must be validated in order for
`reproducibility and robustness. So there's ample evidence in his
`declaration to show that he is knowledgeable about these facts
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`and that he has an understanding of the chiral purity of the
`products that he has been selling or his company has been selling.
`JUDGE YANG: Well, patent owner points out in the
`deposition testimony which Mr. Sawaya said he runs the
`company, and we do agree and we see that he is the president, but
`he also testified that there are many other people who actually do
`the everyday testing and that kind of task. So I believe patent
`owner was trying to argue that given his position and the
`everyday sort of established practice how these two do not seem
`to be consistent.
`MR. DOSHI: Right. But in his cross-examination he
`also states that he runs day-to-day operations of Altaire, and that
`takes up most of his time. Patent counsel was asking him
`questions about Sawaya Aquebogue, and he was making the
`distinction between his role in Sawaya Aquebogue versus Altaire.
`JUDGE YANG: Either you or your co-counsel, if you
`can find out where in his testimony he actually said he did the
`everyday kind of task, we would love to have that. You don't
`have to stop. You can give it to us later if you are concerned
`about your time.
`MR. DOSHI: Okay. Thank you, Your Honor. I do
`want to touch on the optical rotation tests. This is slide 13 that I
`put up as part of the NDA process. The FDA requested chirality,
`chiral purity testing to show the chiral purity of the products that
`were covered by the NDA. Petitioner tested its products and that
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`found that the chiral purity of the formulas that make up lots
`11578 and 11582 which were essentially a hundred percent, and
`you see that on the board.
`JUDGE YANG: It's not only essentially a hundred
`percent, it is actually over a hundred percent, right? So it is purer
`than the pure one.
`MR. DOSHI: So the optical rotation test, the limit for
`the test, and I have highlighted this in slide 13, is minus
`42 degrees to minus 47.5 degrees which will confirm that the
`material being used is in the R form. So both of the samples, the
`Altaire sample in the 11578 and 11582, and I'll focus on 11578,
`fell within that range. And that shows that it is essentially a
`hundred percent pure.
`Now, what Altaire did after that was to compare it
`against the known sample, which is the Sigma-Aldrich control
`sample. That's the -46.3 that you see on the bottom left-hand
`panel of slide 13. It says minus 46.3. So that also falls within the
`test range and therefore, confirms that you are dealing with R
`isomer.
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`Now, what petitioner did was divide the optical rotation
`by the control sample. So the optical value versus the optical
`value of the known sample to get an agreement. So this is
`101.5 percent agreement between the Altaire sample and the
`Sigma-Aldrich sample. So that's where the 101.5 percent comes
`from.
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`JUDGE YANG: So what you are saying is the absolute
`number, as long as it falls in between the 42 and 47.5, would
`show that it is a pure art form? Is that what you are saying?
`MR. DOSHI: That's correct.
`JUDGE YANG: And it does not depend on how you
`operate your machine and all the testing method or all the
`parameters there? Is there any variables? If you take anything
`and just -- you know, I mean, I used to do work in the lab, and
`one batch of experiment and the next batch they could turn out to
`be different.
`MR. DOSHI: Sure. So these were done under another
`test method. I apologize I don't have the number here, but as you
`can see, it says identification study STU-0328 at the bottom there.
`This was validated using the USP monograph which shows you
`how to operate these kinds of tests. So it's a little bit more than,
`you know, whether it was just optical rotation and we got the
`right value. It was done through a validated method and it's in
`agreement with a known sample as well. And the known sample,
`I think it's 27 here, the known sample -- no, I'm sorry, Your
`Honor. Here you go. I'm sorry, slide 33. The known sample was
`greater than or equal to 99 percent. And this is --
`JUDGE YANG: That is patent owner's exhibit, correct?
`MR. DOSHI: It is, correct.
`JUDGE YANG: Here is my question. It sort of relates
`to the question I had earlier. You know, patent owner asserted
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`that the USP standard HPLC method cannot separate the S and R
`form. So if that was the case, then I wonder what this 99 percent
`purity is about, because if you cannot separate the two, then, I
`mean, this 99 percent purity is...
`MR. DOSHI: From Sigma-Aldrich you're referring to?
`JUDGE YANG: Right.
`MR. DOSHI: Sigma-Aldrich must have a way to
`distinguish between the R and S isomers. It's selling not only a
`hundred percent R isomer or close to a hundred percent R isomer,
`but it also sells racemate, as we pointed out in our reply brief
`using exhibits from patent owner. So it has an ability to tell, to
`distinguish the quantity or the quantitative value of the S isomer
`as compared to the R isomer. And this product specification
`shows that it's greater than or equal to 99 percent.
`I will add that we blew up the portion of the bottom of
`that exhibit on slide 33 and it says Sigma-Aldrich warrants that at
`the time the quality release subsequent retest data this product
`conformed to the information contained in this publication. So as
`the witnesses for patent owner, I'm on slide 34, testified, there's
`no reason to doubt the accuracy of a vender's product, that one of
`ordinary skill in the art would have understood and assumed that
`what Sigma-Aldrich is selling is what it is until something goes
`wrong.
`
`And of course, we look at the optical rotation testing,
`going back to slide 13 here, and that shows that it's in compliance
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`with test limits that are set forth by the USP monograph, which is
`minus 42 to minus 47.5. I will also note that Exhibit 2020, which
`is patent owner's exhibit, also corroborates the minus 42 to
`minus 47.5. I don't have a slide on that, but I'm happy to put it on
`the ELMO.
`JUDGE YANG: That's fine. We have it. Thank you.
`MR. DOSHI: I would like to address the real party in
`interest. The Board's preliminary finding and the decision should
`not be disturbed. Nothing from Mr. Sawaya's cross-examination
`changes the findings that Sawaya Aquebogue is a company
`unrelated to petitioner and in a line of business that's different
`from petitioner's and did not direct, control or fund the
`appropriation or filing of the petition. Sorry to read, but I was
`reading from the Board's decision there. All of that was
`confirmed upon cross-examination. I think you'll see some slides
`from patent owner about the veracity of some of Mr. Sawaya's
`testimony, but I wanted to focus in on that language because that
`is the language that the Board used to find that Sawaya
`Aquebogue is not a real party in interest. And I submit that
`nothing has changed from the cross-examination on those points.
`I have about three minutes. I just want to emphasize
`that Altaire was solely responsible for the preparation, funding
`and strategy of this proceeding. There's nothing in the evidence
`to suggest otherwise. And the Sawayas are not RPIs to this
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`proceeding. A stock ownership does not confer RPI
`automatically nor under the facts and circumstances of this case.
`JUDGE PAULRAJ: Do you dispute patent owner's
`contention that Sawaya Aquebogue is a third-party beneficiary to
`the contract between Altaire and Paragon?
`MR. DOSHI: No, Sawaya Aquebogue is a third-party
`beneficiary of the contract.
`JUDGE PAULRAJ: And they do have some vested
`interest in the contract. Isn't the heart of the dispute between the
`parties the contract dispute? Isn't that what brought us all here?
`MR. DOSHI: So the heart of the dispute is the contract
`between Altaire and Paragon. Sawaya Aquebogue is a non-party,
`as patent owner has --
`JUDGE PAULRAJ: But you disagree that Sawaya
`Aquebogue is a beneficiary of that contract. I don't want to get
`into the details because I want to keep this public.
`MR. DOSHI: Is a beneficiary of the contract, yes.
`JUDGE YANG: You have two more minutes left, but
`if needed, I'll give you a couple more. And patent owner, I'll add
`to your time, because I have a question. In your reply, you said
`petitioner waived its objection to, you know, its challenge about
`the petitioner's exhibits. Can you just explain to me which ones
`are they waived, which ones are not? Because they challenge, I
`guess, on different grounds. One is hearsay and the other is
`insufficient details for the experiment. Are you saying both?
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`MR. DOSHI: I am saying both, Your Honor. Sorry to
`interrupt.
`JUDGE YANG: Not a problem. Carry on. Just
`explain to us why are those waived.
`MR. DOSHI: Well, they didn't lodge any objections
`with the Board at the time that was required. I believe it's a
`ten-day requirement, and they did not file any objections or serve
`any objections to us. And so those objections are waived. And
`the admissibility of the evidence should come in. That's our
`position.
`JUDGE YANG: You used the correct term. So those
`objections are related to admissibility. It's under the Federal
`Rules of Evidence, right, those things, for example, hearsay. But
`regarding the sufficiency of the experimental details like your
`principal for that proprietary testing method, could they have
`even objected to that?
`MR. DOSHI: Yes, they could have objected to that
`saying that it was not based on firsthand knowledge or whatever
`they have made their arguments on, they could have objected at
`that point. But they did not object, and therefore, it's our position
`that they waived them. As we said in our reply, had they objected
`in a timely fashion, perhaps we would have supplemented the
`evidence, but we weren't on notice as to whether or not we
`should.
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`Not only that, but I want to make a point that we made
`in our reply brief, which is that patent owner was in possession of
`these details and the testing protocol.
`JUDGE YANG: But it is the Board who evaluates, and
`it is the petitioner's burden. It's not patent owner's responsibility
`to corroborate and say here is your test method, right?
`MR. DOSHI: Understood, Your Honor. But as I
`explained to Judge Paulraj is that we provided sufficient detail
`through Mr. Sawaya's declaration to show that the HPLC
`methodology can distinguish between the R and S. Now, we
`weren't dealing with the USP HPLC method that patent owner
`has, in our view, unreasonably assumed that we were using. The
`preliminary statement by patent owner was the first time that they
`raised the USP HPLC methodology argument. In response, we
`wanted to file a reply. It was limited to the RPI issue. Our first
`chance to address that and to correct the record was through our
`response -- I'm sorry, our reply because the petition had been
`filed over a year ago. And we were not dealing with USP HPLC
`method and that's clear through the declaration and the petition
`that we were relying on the HPLC method.
`I want to say one more thing. If there were any
`questions about the HPLC methodology that was used by
`petitioner, Mr. Sawaya was made available for cross-examination
`and not one question was related to the HPLC methodology. Not
`one question was posed regarding whether he was the one that
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`actually conducted or whether he firsthand -- had firsthand
`knowledge of the experiments that he relies on as president of
`Altaire. So I just want to point that out as well. And with that,
`I'll reserve the rest of my time for rebuttal.
`JUDGE YANG: You guys still need to give us the cite.
`You can do it later when you stand up. I just don't want to forget
`about it. So you took three more minutes.
`So patent owner, you have 48 minutes if you need it.
`MR. ROSATO: We have hard copies of the
`demonstratives. Do you mind if we approach?
`JUDGE YANG: Please.
`MR. ROSATO: Mike Rosato appearing for patent
`owner, Paragon BioTeck. And first off, we would like to thank
`the Board for its time today and throughout the course of the
`proceeding as well as the petitioner. A gratitude of thanks
`extends to them as well.
`I would like to start off by referencing briefly slide 3 of
`the demonstrative exhibits. And while this has been addressed, I
`just want to emphasize that there is one single ground on which
`trial was instituted, and that ground was obviousness of the
`claims of the '623 patent in view of Altaire's phenylephrine
`product in view of knowledge of a person of ordinary skill in the
`art. That product specifically relied upon consisted of lots 11578
`and 11581. Now, Altaire represents that those lots were
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`manufactured in December 2011 and corresponding product was
`sold in October 2012.
`I'm going to turn to slide 4 just to briefly look at the
`claim and just a point of emphasis which I'm sure is not lost on
`the Board, and t
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